Catheter probe arrangement for tissue analysis by radiant energy delivery and radiant energy collection

ABSTRACT

A catheter tip apparatus arranged in a catheter for the delivery and collection of a light-energy signal to permit subsequent computerized analysis of body tissue by the collected signal. The apparatus comprises an elongated housing supporting a first reflective surface and a second reflective surface. The first reflective surface and the second reflective surface are longitudinally spaced apart from one another. A first flexible, elongated energy bearing delivery fiber has a distalmost end arranged adjacent the first reflective surface. A second flexible, elongated energy bearing collection fiber has a distalmost end arranged adjacent the second reflective surface. The housing is rotatably supported on a flexible catheter sheath for insertion of the catheter into a mammalian body for tissue analysis thereof.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] This application relates to photo-medical devices, and moreparticularly to photo-medical devices that deliver and collect radiantenergy to permit body tissue analysis and/or treatment, and isco-pending with commonly assigned patent application Ser. No. ______,entitled “Multi-Fiber Catheter Probe Arrangement for Tissue Analysis orTreatment” (InFraReDx-14) which is incorporated herein by reference inits entirety.

[0003] 2. Prior Art

[0004] The sensing and treating of various tissue characteristics in thein vivo intravascular environment is desirous for many reasons yetdifficult because it is a very harsh environment in which to conductsuch analysis or treatment. The presence of blood and its constituentssuch as cholesterol may effect scattering and absorption of energysignals transmitted within an organ. Diagnosis and treatment of varioustissues within the human body using an in vivo probe necessitatesadaptive characteristics for that probe when it is inserted into amammalian body organ.

[0005] It is an object of the present invention to provide a probe forinsertion within a mammalian body which overcomes the disadvantages ofthe prior art.

[0006] It is a further object of the present invention to provide aminimally invasive device for light energy transmitting (i.e. infraredthrough ultraviolet) diagnosis and treatment of mammalian tissue throughthe use of endoscopes, catheters and other minimally invasive devices.It is still yet a further object of the present invention to provideoptical probe tip arrangement which facilitates optimum delivery andretrieval of energy signals within the human body tissue.

BRIEF SUMMARY OF THE INVENTION

[0007] The present invention provides several preferred embodiments ofapparatus and of method of use of that apparatus to analyze body tissueusing an energy spectrum analysis distributed and received by anelongated probe introducable through a catheter into that body tissue.That introduction of the body probe may be done through an endoscope, orother catheter-like devices for such energy diagnosis and treatment oftissue. That energy analysis and treatment may include near infrared(NIR) reflectance spectroscopy, Raman spectroscopy, fluorescencespectroscopy, photodynamic drug activation, photonic ablation or thermaltreatments, and optical coherence tomography.

[0008] The probe of the present invention comprises an elongated,generally cylindrically shaped housing having a first or distal end anda second, or proximal end. The proximal end has a stem thereon ofreduced diameter from the diameter of the distalmost portion thereof. Anelongated groove is arranged to extend from the proximal end of the stemthrough towards the distal end of the housing. The groove is disposedthrough only one side of the housing, and has an arrangement of angledshoulders therein for providing snug receipt of the collector and thedelivery fiber arrangement.

[0009] The collector fiber arrangement in this particular embodimentincludes an elongated flexible collection fiber having a distal end towhich a reflector or reflective surface (i.e., a mirror member) isattached. The collection fiber has an outer buffer such as a sheath forprotection of the fiber and to minimize stray radiation therefrom. Amirror member has an angularly disposed reflective surface thereon. Thedelivery reflector (or mirror member) is attached to an optical deliveryfiber which is enclosed similarly by an outer buffer such as a sheathfor protection of the fiber and for minimization of light leakage. Thedelivery reflector or mirror member has an angled reflective surfacethereon. The collection fiber and reflector and the delivery fiber andreflector jointly mate within the elongated receiving groove within thestem and tip housing. The elongated groove is preferably shaped toeffect accurate positioning of the respective reflectors or mirrormembers therein, so as to emit radiation from the delivery reflector (ormirror member) and receive radiation reflected back from a body tissuesample in the collection reflector (or mirror member). Once thecollection and delivery fibers are within the housing, those jointfibers may be inserted within an elongated catheter shaft or rotatablecoil as will be described hereinbelow.

[0010] A further embodiment of the present invention is disclosed by aelongated support frame having a proximal end and a distal end. Theproximal end includes and upstanding portion through which a collectionfiber channel is arranged (i.e., molded, drilled, machined). Arectilinearly-shaped holding pocket is arranged distal of the firstupstanding member and is arranged to receive a reflective mirroredsurface for example, a collection prism, thereon. A midblock portion isarranged centrally in the support frame and has a delivery fiber channelarranged therewithin, the delivery fiber channel extending parallel andadjacent the collection fiber channel. A second holding pocket issimilarly arranged adjacent the delivery fiber channel for receipt of asecond reflector such as a reflective mirrored surface, such as forexample, a mirror member, having a mirrored surface thereon. The holdingpockets are constructed so as to accurately receive and align therespective first and second mirror members to the desired angle for thedesired photon delivery and photon collection from a target body tissue.The elongated support frame is arranged within an elongated housing,having an elongated channel for receipt thereof. A delivery fiber and acollection fiber would be inserted within their respective channels andthe respective reflectors (i.e. mirror members) would be secured (i.e.affixed by adhesive) within their respective holding pockets.

[0011] A further embodiment of the optical probe arrangement of thepresent invention is characterized by a generally cylindrically shapedframe member having a stepped down stem portion on its proximal endthereof. The frame member is arranged so as to define a series of distalstep portions, the first portion of which is arranged to receive acollection reflector (i.e. mirror member or reflective surface) andsecond stepped portion receives a delivery reflector (i.e. mirror memberor reflective surface). A bore or channel is arranged through the framemember for servicing each particular reflector. Each respective channelreceives an optical fiber which is arranged to abut one surface of itsrespective reflector. The distal cover may be arranged so as to mateover the respective collection reflector and the delivery reflectorwhile having a slot for passage of a photonic signal therethrough. Thedelivery reflector is thus permitted to emit photonic radiation and thecollection reflector is permitted to receive photonic radiation when theframe member is assembled with the cover, and the stem is attached inholding the particular fiber, and those fibers are inserted within ahollow torqueable transmission shaft such as a counterwound, multifilardrive shaft coil arrangement proximal of that frame member.

[0012] A further embodiment of the probe arrangement is shown by anelongated frame member having a proximal end and a distal end. Theproximal end of that frame member is arranged so as to define an angledreflective surface thereat, the distal end of that frame member having asecond reflective surface angularly disposed thereon with an oval endcap thereon. A bore is arranged through the proximal end of theelongated frame member to define a receiving channel for a deliveryfiber to be inserted therewithin. The entire elongated frame member isinserted into an elongated cylindrically shaped housing having aproximal end and a distal end. The proximal end of the housing has astem of stepped down diameter, which stem encloses an energy deliveryfiber and an energy collection fiber. The stem of the housing isarranged to receive the collection fiber which is arranged to receivereflective signals from its reflector surface arranged onto theelongated frame member. The housing has an opening arrangedlongitudinally therein, so as to receive the elongated frame member. Thehousing also has a slot cut through a side portion thereof so as topermit the energy signal to be delivered and received by the respectivereflective surfaces contained therewithin. The end cap on the distalmostend of the elongated frame member abuts the distalmost end of theelongated housing to define a smooth continuous surface therearound.

[0013] A further embodiment of the present invention resides in a onepiece housing of generally cylindrical shape having a proximal portionof stepped down diameter defining a stem. A first reflective collectionsurface is disposed at a particularly desired angle adjacent the stem ofthe elongated housing, and a second reflective surface is arranged intothe elongated housing adjacent its distalmost end. A first bore isarranged through the housing through the stem so as to receive acollection fiber. A second bore is also arranged through the elongatedhousing so as to support a delivery fiber therethrough. The stem may bereceived in a pair of hollow, flexible, counterwound coils whichfunction as a torqable transmission shaft which is secured to the stemand surrounds the delivery and collection fibers received therethrough.The first and second reflective surfaces arranged in the housing, inthis embodiment, may be skewed (non-parallel or curvilinear) so as toemit and receive signals from any particular direction with respect toits adjacent reflective surface.

[0014] A yet further embodiment of the present invention relates to amethod of constructing a catheter tip arrangement for support of aplurality of optical fibers, which support construction permitsminimization of component size and adaptive angularity of reflection ofthe delivery and collection beams. Such a support may be accomplished bymicromachining construction where additive processing such as forexample: plating, sputtering, vapor deposition, and subtractiveprocessing such as for example: etching, laser cutting and ablation,permits finite adjustment to the dimensions. The support comprises abase upon which an arrangement of parallel bosses are “grown”, thebosses defining between them, a pair of parallel slots into which adelivery and a collection fiber may be mated. A mirror surface andsupport struts are spaced at the distalmost location of the fibers,which mirror surface may be curved or manipulably bent to the desiredangle for maximizing optical analysis and tissue treatment thereby. Thisembodiment contemplates the use of index-matching fluids added to anygap between a catheter sheath surrounding the fibers to reduce any backreflections from the interior of the protective sheath/transmissionwindow.

[0015] The invention thus comprises a catheter tip apparatus arranged ina catheter for the delivery and collection of a light energy signal topermit subsequent computerized analysis of body tissue by the collectedsignal. The apparatus comprises an elongated housing member supporting afirst reflective surface and a second reflective surface. The firstreflective surface and the second reflective surface are longitudinallyspaced apart from one another. A first flexible, elongated, light energybearing delivery fiber has a distalmost end arranged adjacent the firstreflective surface. A second flexible, elongated energy bearingcollection fiber has a distalmost end arranged adjacent the secondreflective surface. The housing member is rotatably supported on aflexible catheter sheath for insertion of the catheter into a mammalianbody for tissue analysis thereof. The housing may comprise a framemember having a slot arranged therein for receipt and alignment of thefirst and the second reflective surfaces. The first and the secondreflective surfaces may comprise prism members. The slot may haveshoulders therein to secure and accurately align the reflective surfacestherein. The housing may have a proximalmost stem portion for receiptinto a catheter sheath to permit manipulation of the tip from a proximallocation. The housing may be comprised of a frame member having aproximal end and a distal end, with an upstanding proximal block and anupstanding midblock, each block having a holding pocket thereadjacentfor receipt of a reflective surface attachable therein. The reflectivesurface may comprise a prism fixedly attached into the pocket. Each ofthe upstanding blocks may have a bore therethrough for receipt of one ofthe energy bearing fibers. The housing may comprise an elongatedgenerally cylindrically shaped frame member with a proximal end and adistal end, the frame member having at least two steps thereon ofdecreasing thickness in the distal direction, each of the steps having areflective surface mounted thereon, the proximal end having a stemportion of reduced diameter, to permit rotative receipt within a tubularcatheter sheath. The frame member may have a cover member arranged tomate over the steps and the reflective surfaces of the housing. Thecover member may have an axially arranged slot thereon through part ofits longitudinal length, the slot being disposed radially adjacent eachof the reflective surfaces to permit delivery and reflected collectionof an energy beam therethrough. The stem portion may be secured to amulti-layered, elongated coil spring arrangement to permit twistingcontrol of the catheter tip within a mammalian body component. Thereflective surfaces may be unitary portions of the housing. The housinghas a proximal end and a distal end, and the proximal end may mate witha housing enclosure, the enclosure providing a securement means for theenergy collecting fiber and the housing providing a securement means forthe energy delivery fiber. The housing enclosure attached to saidproximal end of said housing may have a longitudinally directedelongated slot therein, the slot being in radial alignment with thereflective surfaces formed on the housing to permit transmission andcollection of radiant energy via the respective reflective surfaces to acomputerized analysis system. The housing may comprise a cylindricallyshaped member having its first and second reflective surfaces machinedthereon, and wherein the first and second reflective surfaces arenon-parallel with respect to one another. The first and second fibersmay be diametrically oppositely arranged with respect to thelongitudinal axis of rotation of the housing, to minimize any undesiredmotion of the housing during its rotation in a body tissue. The housingmay include a reflective surface which is bendable to effect directionalchange of an energy beam reflecting therefrom. The housing may be madeof “accumulation” or “deletion” components defining a fiber alignmentslot for miniaturization of the tip.

[0016] The present invention also comprises a catheter tip apparatusarranged in a catheter for the delivery and collection of an energysignal to permit subsequent computerized analysis of body tissue by thecollected signal. The apparatus comprises an elongated housing having alongitudinal axis of rotation, the housing having a first reflectivesurface disposed thereon, a second reflective surface disposed on thehousing distally of the first reflective surface and in axial alignmenttherewith; and a first light conductive fiber in light coupledcommunication with the first reflective surface and a second lightconductive fiber in light coupled communication with the secondreflective surface, the first light conductive fiber in communicationbeing in communication with a controlled analytical-light generatingsource and the second light conductive fiber being in communication witha light-collection analysis device. The first reflective surface may bedimensionally larger than the second reflective surface. The firstreflective surface may be curvilinear. The first reflective surface maybe non-parallel with respect to the second reflective surface. At leastone of the first and second reflective surfaces may be spaced apart fromthe light conductive fibers. The first reflective surface may bedisposed radially within and spaced from the perimeter of the housing topermit a spreading of a light beam from the first reflective surfaceonto the body tissue. An index matching fluid may be arranged between adistal end of the conductive fiber and the reflective surface. Thereflective surface may be positioned in a holding pocket arranged in thehousing. The reflective surface may be comprised of a mirrored surface.The holding pocket may be utilized to align the reflective surface withrespect to the housing. The conductive light fibers may be eachindividually arranged within a bore disposed within the housing. Thelight delivery fibers may be equally diametrically opposed about theaxis of rotation of the housing to provide balance thereto and minimizeeccentricity during rotation thereof.

[0017] The invention may also comprise a catheter tip apparatus arrangedin a catheter for the delivery and collection of an energy signal topermit subsequent computerized analysis of body tissue by the collectedsignal, the apparatus comprising an elongated housing having alongitudinal axis of rotation, the housing having a first reflectivesurface disposed thereon, a second reflective surface disposed on thehousing distally of the first reflective surface and in axial alignmenttherewith. A first light conductive fiber may be in light-coupledcommunication with the first reflective surface and a second lightconductive fiber in light-coupled communication with the secondreflective surface, the first light conductive fiber in communicationbeing in communication with a controlled analytical-light generatingsource and the second light conductive fiber being in communication witha light-collection analysis device. A curvilinear cover may be arrangedto mate over a distal portion of the housing to enclose the reflectivesurfaces, the cover having at least one opening on an annular surfacethereof to permit light delivery to the body tissue, and to permit lightcollection therethrough upon reflection from the body tissue. At leastone of the reflective surfaces may comprise a mirror or polishedsurface. Each of the light conductive fibers has a distal end arrangedwithin said housing, and the at least one of the light conductive fibersis in abutting relationship with a non-reflective surface of the membercontaining the reflective surface. At least one of the reflectivesurfaces may be disposed in a holding pocket. The reflective surface maybe secured in the holding pocket by an adhesive.

[0018] The invention also comprises a catheter tip apparatus having afirst reflective surface and said second reflective surface which aredisposed at an angle proportional to the numerical aperture of the firstand second foptical ibers, to yield a light beam with adjacent edgesthat are parallel to one another, to permit a distance independentdelivery reflector-collector reflector separation.

[0019] The invention may also comprise a catheter tip apparatus arrangedin a catheter for the delivery and collection of an energy signal topermit subsequent computerized analysis of body tissue by the collectedsignal, comprising an optically transparent sheath enclosed elongatedhousing having a longitudinal axis of rotation, the housing having afirst reflective surface disposed thereon, a second reflective surfacedisposed on the housing distally of the first reflective surface and inaxial alignment therewith, a first light conductive fiber in lightcoupled communication with the first reflective surface and a secondlight conductive fiber in light coupled communication with the secondreflective surface, the first light conductive fiber in communicationbeing in communication with a controlled analytical-light generatingsource and the second light conductive fiber being in communication witha light-collection analysis device. A generally curvilinear cover may bearranged to mate over a distal portion of the housing to enclose thereflective surfaces, the cover having at least one opening on an annularsurface thereof to permit light delivery to the body tissue, and topermit light collection therethrough upon reflection from the bodytissue. At least one of the reflective surfaces may comprise a mirroredmember. Each of said light conductive fibers may have a distal endarranged within the housing, and the at least one of the lightconductive fibers is in abutting relationship with a non-reflectivesurface of the mirrored member. At least one of the reflective surfacesmay be disposed in a holding pocket. The reflective surface may besecured in the holding pocket by an adhesive. An index matching fluidmay be disposed about the reflective surfaces to minimize backreflections thereto, from the outer sheath.

[0020] The invention may also comprise a catheter tip apparatus arrangedin a catheter for the delivery and collection of an energy signal topermit subsequent computerized analysis of body tissue by the collectedsignal, comprising an optically transparent sheath enclosed elongatedhousing having a longitudinal axis of rotation. The housing may have afirst reflective light delivery surface disposed thereon and a firstreflective light collection surface disposed on the housing distally ofthe first reflective light delivery surface and in axial alignmenttherewith. A first light conductive fiber is in light coupledcommunication with the first reflective light delivery surface and asecond light conductive fiber is in light coupled communication with thefirst reflective light collection surface, the first light conductivefiber in being in communication with a controlled analytical-lightgenerating source and the second light conductive fiber being incommunication with a light-collection analysis device, and a secondreflective light collection surface may be disposed on the housingdistally of the first reflective light collection, the second reflectivecollection surface may also be in communication with the controlledanalytical-light generating source and in axial alignment therewith. Thefirst and second reflective surfaces are thus arranged to permit deeptissue light energy penetration and collection and analysis thereby.Reflectors may otherwise be known as beam redirecting members comprisedof aspheric members, planar, spherical, convex surfaces, concavesurfaces, comprised of mirrors, dielectric mirrors, refractive indexinterfaces or diffractive optical elements.

[0021] The invention may also include a method of delivering andcollecting a tissue-striking light energy signal from a first lightfiber and adjacent delivery reflector and returning said light energysignal to a collection reflector adjacent a second light fiber foranalysis and tissue treatment. The method includes spacing thecollection reflector distally of the delivery reflector in a sheathenclosed elongated catheter housing tip, the housing having alongitudinal axis; disposing the reflectors at an angle with respect tothe longitudinal axis of the elongated housing proportional to anumerical aperture of the first and second energy fibers. The method mayinclude bathing the reflectors in an index matching fluid to minimizeback reflection in the sheath enclosed housing, and directing thedelivery light energy signal and the collection light energy signal soas to yield adjacent edges thereof that are parallel.

[0022] Thus what has been shown as a unique arrangement of structuresfor supporting energy carrying fibers such as flexible optical fibers topermit particular radiation to be delivered from one reflective surfaceand collected on a second adjacent reflective surface and analyzed in acomputer apparatus at the proximal end of those fibers.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The objects and advantages of the present invention will becomemore apparent when viewed in conjunction with the following drawings inwhich:

[0024]FIG. 1 is an exploded view of a probe housing and an optical fiberarrangement adaptable for insertion into a mammalian body;

[0025]FIG. 2 is a view similar to FIG. 1, showing the fiber componentsarranged within the elongated housing;

[0026]FIG. 3 is an exploded view in perspective, of a prism and supportframe arrangement and a housing for that support frame, for attachmenton the distal end of a set of optical fibers;

[0027]FIG. 4a is a view of a collection and delivery probe arranged onthe distal end of a transmission coil in a perspective view thereof;

[0028]FIG. 4b is an exploded view of the coil and probe components shownin FIG. 4a;

[0029]FIG. 5a is a perspective view of an assembly of an elongatedhousing having a pair of reflective surfaces arranged therewithin;

[0030]FIG. 5b is a view similar to FIG. 5a showing the frame componentsthereof without the surrounding elongated housing;

[0031]FIG. 6a is a perspective view of a probe assembly showing a onepiece housing arrangement with optical fibers in a counterwound coil;

[0032]FIGS. 6b, 6 c and 6 d are side elevational views of the housingshown in FIG. 6a;

[0033]FIG. 7 shows a perspective view of a fiber supporting catheter tiphousing arrangement manufactured by additive and subtractive methods;

[0034]FIG. 8 shows a schematic representation of multiple collectionfibers in a housing; and

[0035]FIGS. 9a and 9 b show reflectors arranged in their elongatedhousing for parallel light reflective beams.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] Referring now to the drawings in detail, and particularly to FIG.1, there is shown a first embodiment of the present invention whichcomprises a catheter tip apparatus 10 and a method of use of thatapparatus 10 to provide an analysis of body tissue using an energyspectrum analysis distributed and received by an elongated probe 12introducable through a catheter sheath 14 into that body tissue. Thatintroduction of the catheter sheath 14 and body probe 12 may be donethrough an endoscope, or other catheter-like devices, not shown, forsuch energy diagnosis and treatment of tissue by a proper computerapparatus 15. The energy analysis and treatment might includefluorescence spectroscopy, near infrared (NIR) reflectance spectroscopy,Raman spectroscopy, and optical coherence tomography, photodynamic drugactivation, photonic ablation and thermal treatments.

[0037] The probe 12 of the present invention comprises an elongated,generally cylindrically shaped housing 16, as shown in FIGS. 1 and 2,having a first or distal end 18 and a second or proximal end 20. Theproximal end 20 has a stem 22 thereon of reduced diameter from thediameter of the distalmost 18 portion thereof. An enlongated groove 24is arranged to extend from the proximal end 20 of the stem 22 throughtowards the distal end 18 of the housing 16, as may be seen in FIGS. 1and 2. The groove 24 extends only through one side of the housing, andhas an arrangement of angled shoulders 26 and 28 therein for providingsnug receipt of the collector fiber 30 and the delivery fiber 32.

[0038] The collector fiber arrangement in this particular embodimentincludes the elongated flexible collection fiber 30 having a distal end34 to which a reflector or reflective surface 36 (i.e. mirrored/polishedmember) is attached. The collection fiber 30 has an outer buffer 38, forprotection of the fiber and to minimize stray radiation therefrom. Thereflector 36 has an angularly disposed reflective surface 40 thereon.

[0039] The delivery reflector 42 is attached to an optical deliveryfiber 44 which is enclosed similarly by an outer buffer 46 such as asheath for protection of the fiber and for minimization of lightleakage. The delivery reflector 42 has an angled reflective surface 48thereon. The collection fiber 30 and attached reflector 36 and thedelivery fiber 44 and its attached reflector 42 jointly mate within theelongated receiving groove 24 within the stem and tip housing 16. Theelongated groove 24 is preferably shaped to effect accurate positioningof the respective reflectors 36 and 42 therein, so as to emit radiationfrom the delivery reflector 42 and receive radiation reflected back froma body tissue sample through the collection (reflector) 36. Once thecollection and delivery fibers 30 and 44 are within the housing 16,those joint fibers 30 and 44 may be inserted within the elongatedcatheter shaft 14 or rotatable coil as will be described hereinbelow. Afurther embodiment of the present invention shown in FIG. 3 and isdisclosed as an elongated support frame 50 having a proximal end 52 anda distal end 54. The proximal end 52 includes an upstanding portion 56through which a collection fiber support and alignment channel 58 isarranged (i.e. molded, drilled, machined). A rectilinearly-shapedholding pocket 60 is arranged distal of the first upstanding member 56and is arranged to receive a reflective mirrored surface 62, (forexample, a reflective collection member) having a reflecting surface 64thereon. An upstanding midblock potion 66 is arranged centrally of thesupport frame 50 and has a delivery fiber support and alignment channel68 arranged therewithin. The delivery fiber channel 68 extends paralleland adjacent the collection fiber channel 58. A second holding orreceiving pocket 70 is similarly arranged distally adjacent the midblockportion 66 for adhesive receipt of a second reflector or mirroredsurface (i.e. mirror or reflective member) 72 having a mirrored surface74 thereon. The holding pockets 60 and 70 are constructed so as toaccurately receive and align the respective first and second reflectorarrangements (i.e. mirrors or reflective members) 62 and 72 to thedesired angle for the desired photon delivery and photon collection froma target body tissue, not shown for clarity. The elongated support frame50 is arranged within an elongated generally U-shaped housing 76, havingan elongated channel 78 for receipt thereof. A delivery fiber and acollection fiber would be inserted within their respective channels 68and 58 and the respective reflectors (i.e. reflective members/mirrors)72 and 62 would be secured (i.e. affixed by adhesive) within thoserespective holding pockets 70 and 60.

[0040] A further embodiment of the optical probe arrangement of thepresent invention is shown in FIGS. 4(a) and 4(b) and is characterizedby a generally cylindrically shaped frame member 80 having a steppeddown stem portion 82 on its proximal end thereof, as may be seen in FIG.4(b). The frame member 80 is arranged so as to define a series of distalstep portions 84 and 86, the first portion 84 of which is arranged toreceive a collection reflector (i.e. reflective member or reflectivesurface) 88 and the second stepped portion 86 receives a deliveryreflector (i.e. reflective member or reflective surface) 90. A bore orchannel 92 and 94 is arranged through the frame 80 for servicing eachparticular reflector 88 and 90. Each respective channel 92 and 94receives a collection fiber 96 or an optical fiber 98 which is arrangedto abut a planar surface 100 and 102 of its respective reflector 88 and90. A distal cover 104 as shown in FIG. 4(a) may be arranged so as tomate over the respective collection reflector 88 and delivery reflector90 while having a slot 106 for passage of a delivered or receivedphotonic signal therethrough. The delivery reflector 90 is thuspermitted to emit photonic radiation and the collection prism 88 ispermitted to receive photonic radiation when the frame 80 is assembledwith the cover 104 and the stem 82 is attached and holding theparticular fibers 96 and 98, and those fibers 96 and 98 are insertedwithin a hollow, torqueable transmission shaft such as a counter woundmultifilar drive shaft coil arrangement 108 proximal of that framemember 80 and secured to the stem 82.

[0041] A further embodiment of the probe arrangement of the presentinvention is shown in FIGS. 5(a) and 5(b) by an elongated frame member116 having a proximal end 118 and a distal end 120, as may be best seenin FIG. 5(b). The proximal end 118 of that frame member 116 is arrangedso as to define an first angled reflective surface 122 at an uprightportion 124 thereof, the distal end 120 of that frame member 116 havinga second upright portion 125 with a second reflective surface 126angularly disposed thereon with an oval end cap 128 thereon. A bore 130is arranged through the upright portion 124 on the proximal end 118 ofthe elongated frame member 116 so as to define a receiving channel for adelivery fiber 132 to be inserted therewithin. The entire elongatedframe 116 is inserted into an elongated housing 134, as shown in FIG.5(a), having a proximal end 136 and a distal end 138. The proximal end136 of the housing 134 has a stem 140 with a stepped down diameter whichencloses the delivery fiber 132 and a collection fiber 142. The stem 140of the housing 134 is arranged to receive the collection fiber 142 whichis arranged to receive reflective signals from its reflection surface122 arranged onto the upstanding portion 124 of the elongated framemember 116. The housing 134 has an opening 144 arranged longitudinallytherein, as shown in FIG. 5(a), so as to receive the elongated framemember 116. The housing 134 also has a slot 146 cut through its sideportion thereof so as to permit the photonic energy signal to bedelivered and received by the respective reflective surfaces 126 and 122contained therewithin. The end cap 128 on the distalmost end 120 of theelongated frame member 116 abuts the distalmost end 138 of the elongatedhousing 134 to define a smooth continuous surface therearound.

[0042] A further embodiment of the present invention resides in a onepiece housing 150 of generally cylindrical shape, (as may be seen inFIGS. 6(a), 6(b), 6(c) and 6(d)), having a proximal portion 152 ofstepped down diameer defining a reduced-diameter fiber-enclosing stem154. A first reflective collection surface 156 is disposed at aparticularly desired angle near the stem 154 of the housing 150, and asecond reflective surface 158 is disposed onto the elongated housing 150adjacent its distalmost end 160. A first channel or bore 162 is arrangedthrough the proximal end 152 of the housing 150 adjacent the stem 154 soas to snugly and alignably receive a signal collection fiber 164. Asecond channel or bore 166 is also arranged through the proximal half ofthe elongated housing 150 so as to alignably support a delivery fiber168 therethrough. The stem 154 may be received in a pair of hollow,flexible, counterwound coils 170, as shown in FIG. 6(a), which coils 170that function as a torqueable transmission shaft, is secured to the stem154 and surrounds the delivery and collection fibers 168 and 164received therethrough. The first and second reflective surfaces 156 and158 arranged into the housing 150, in this embodiment, and which isdepicted by light energy waves E1 and E2 reflecting with respectthereto, may be skewed (non parallel or curvilinear) with respect to oneanother so as to emit and receive signals from any particular directionwith respect to the surface of an adjacent reflective tissue “T”. FIG.6(c) represents the housing 150 with the respective reflective surfaces156 and 158 being spaced further longitudinally apart than is depictedin FIG. 6(b). This permits different scattering patterns E1 and E2 to bedelivered and hence received by the catheter tip apparatus 10. FIG. 6(d)represents the manufactured reflective surfaces 156 and 158 at a skewedangle with respect to one another to present further signal delivery andcollection characteristics with respect thereto. The fiber bores 154 and162 are oppositely aligned and diametrically disposed across thelongitudinal axis of rotation “R” of the housing 150. This minimizeseccentric rotation of the housing 150, the fibers borne therein andsignal distortion during rotation of the housing 150 in a body vesselduring analysis of tissue “T”.

[0043] A yet further embodiment of the present invention is shown inFIG. 7, wherein a platform 180 relates to a method of constructing acatheter tip arrangement 10 for support of a plurality of two or moreoptical delivery and collection fibers 182 and 184, which “support”construction permits minimization of component size and adaptiveangularity of reflection of the delivery and collection beams B1 and B2.Such a support platform 180 may be accomplished by micro-machiningconstruction where additive or subtractive processing such as forexample: etching, plating, sputtering, vapor deposition and subtractiveprocessing such as etching, laser cutting and ablation permits finiteadjustment to the dimensions. The support platform 180 comprises a base186 upon which an arrangement of elongated, parallel bosses 188, 190 and192 are “grown”, the bosses 188, 190 and 192 defining between them, apair of parallel slots 194 and 196 into which a delivery and acollection fiber 182 and 184 may be respectively mated. A mirror surface198 and 200 and support struts 200 and 202 are spaced at the distalmostlocation of the fibers 182 and 184, which mirror surfaces 198 and 200may be curved or manipulably bent to the desired angle for maximizingoptical analysis and tissue treatment thereby. This embodiment shown inFIG. 7 contemplates the use of index-matching fluids 206 added to anygap between a catheter sheath 204 surrounding the fibers 182 and 184, toreduce any back reflections from the interior of the protectivesheath/transmission window.

[0044]FIG. 8 shows a schematic representation of a catheter tip disposedelongated housing 210 having an optical energy delivery fiber 212 and afirst optical energy collection fiber 214 and a second optical energycollection fiber 216 in optical communication with a mammalian tissue“T8”. Each fiber 212, 214 and 216 have a reflective surface 218, 220 and222 disposed distally thereof respectively, as shown in FIG. 8. Thereflective surfaces 218, 220 and 222 are axially spaced apart from oneanother. Multiple collection fibers 214 and 216 with axially spacedapart collection reflective surfaces 220 and 222 permit collection andanalysis of light that has penetrated more deeply into the tissue “T8”.The reflective surfaces 218, 220 and 222 may be aspheric volumes, orflat, convex, concave or curved members having an arcuate surface topresent a straight reflective beam, a spread-out beam, a focused beamwhich may overlap one another, be parallel to one another, or inalignment with one another. Multiple collectors 220 and 222 permits thereceiving or collection of light emitted from a single source butcollected from more than one collector arranged at spaced apartlocations within the tissue being investigated. The beams may have adelivery numerical aperture NA of between NA=0.1 and NA=0.6 and acollection numerical aperture NA of between NA=0.1 and NA=0.7. Beanredirecting members such as mirrors preferably have separations of about0.1 mm and 2 mm.

[0045] A more preferential delivery and collection beam geometry isshown in FIGS. 9a and 9 b having a catheter tip disposed elongatedhousing 230 having an optical delivery fiber 232 and an optical energycollection fiber 234 in optical communication with mammalian tissue “9a”. A reflective surface 236 delivers a generally radially deliveredlight beam L9 and a reflective surface 238 collects the generallyradially directed returning light beam L9. Adjacent portions of thedelivered beam and the returning beam in this embodiment are parallel,because the delivery and collection reflectors 236 and 238 are disposedat chosen angles proportional to the numerical aperture of the deliveryand collection fibers 232 and 234 to yield energy beam having edges thatare parallel to permit distance independent delivery-collectorseparation, such angularity of the reflectors 236′ and 238′ being shownat a less steep angle with respect to the longitudinal axis A9, in anelongated housing 230′, represented in FIG. 9b. It is also contemplatedthat each fiber may be utilized for both delivery and collection oflight energy.

[0046] Thus what has been shown as a unique arrangement of structuresfor supporting energy carrying fibers or waveguide elements to permitparticular radiation to be delivered from at least one beam redirectingmember such as a reflective surface and collected on the same or atleast a second adjacent beam redirecting member such as a secondreflective surface and analyzed in a light signal analyzer computerapparatus connected to the proximal end of those fibers, waveguides orbeam bearing members.

I claim:
 1. A catheter tip apparatus arranged in a catheter for thedelivery and collection of an energy signal to permit subsequent lightenergy beam analysis of body tissue by the collected signal, comprising:an elongated housing supporting a first reflective surface and a secondreflective surface, said first reflective surface and said secondreflective surface being longitudinally spaced apart from one another; afirst flexible, elongated energy bearing delivery fiber having adistalmost end arranged adjacent said first reflective surface; a secondflexible, elongated energy bearing collection fiber having a distalmostend arranged adjacent said second reflective surface; and said housingrotatably supported on a flexible catheter sheath for insertion of saidcatheter into a mammalian body for tissue analysis thereof.
 2. Thecatheter tip apparatus as recited in claim 1, wherein said housingcomprises a frame member having a slot arranged therein for receipt andalignment of said first and said second reflective surfaces.
 3. Thecatheter tip apparatus as recited in claim 1, wherein said firstreflective surface and said second reflective surface each comprise abeam redirecting member.
 4. The catheter tip apparatus as recited inclaim 2, wherein said slot has shoulders therein to guideably secure andaccurately align said reflective surfaces therein.
 5. The catheter tipapparatus as recited in claim 2, wherein said housing has a proximalmoststem portion for receipt into a catheter sheath to permit manipulationof said tip from a proximal location.
 6. The catheter tip apparatus asrecited in claim 1, wherein said housing comprises a frame member havinga proximal end and a distal end, with an upstanding proximal block andan upstanding midblock, each block having a pocket thereadjacent forreceipt of a reflective surface attachable therein.
 7. The catheter tipapparatus as recited in claim 6, wherein said reflective surfacecomprises a mirror glued into said pocket.
 8. The catheter tip apparatusas recited in claim 6, wherein each of said upstanding blocks has a boretherethrough for receipt of one of said energy bearing fibers.
 9. Thecatheter tip apparatus as recited in claim 1, wherein said housingcomprises an elongated generally cylindrically shaped frame member witha proximal end and a distal end, said frame member having at least twosteps thereon of decreasing thickness in the distal direction, each ofsaid steps having a reflective surface mounted thereon, said proximalend having a stem portion of reduced diameter, to permit rotativereceipt within a catheter sheath.
 10. The catheter tip apparatus asrecited in claim 9, wherein said frame member has a cover memberarranged to mate over said steps and said reflective surfaces.
 11. Thecatheter tip apparatus as recited in claim 10, wherein said cover memberhas an axially arranged slot thereon through part of its longitudinallength, said slot being disposed radially adjacent each of saidreflective surfaces to permit delivery and reflected collection of anenergy beam therethrough.
 12. The catheter tip apparatus as recited inclaim 9, wherein said stem portion is secured to a multi-layered,elongated coil spring arrangement to permit twisting control of saidcatheter tip within a mammalian body component.
 13. The catheter tipapparatus as recited in claim 1, wherein said reflective surfaces areunitary portions of said housing.
 14. The catheter tip apparatus asrecited in claim 13 wherein said housing has a proximal end and a distalend, and said proximal end mates with a housing enclosure, saidenclosure providing a securement means for said energy collecting fiberand said housing provides a securement means for said delivery fiber.15. The catheter tip apparatus as recited in claim 14, wherein saidhousing enclosure attached to said proximal end of said housing has alongitudinally directed elongated slot therein, said slot being inradial alignment with said reflective surfaces formed on said housing topermit transmission and collection of radiant energy via said respectivereflective surfaces to a computerized analysis system.
 16. The cathetertip apparatus as recited in claim 1, wherein said housing comprises acylindrically shaped member having said first and second reflectivesurfaces machined thereon, and wherein said first and second reflectivesurfaces are non-parallel with respect to one another.
 17. The cathetertip apparatus as recited in claim 16, wherein said first and secondfibers are diametrically oppositely aligned with respect to one anotherabout a longitudinal axis of rotation of said housing, to minimizeeccentricity of rotation of said catheter housing during rotation ofsaid housing in a body tissue.
 18. The catheter tip apparatus as recitedin claim 1, wherein said housing includes a reflective surface which isbendable to effect directional change of an energy beam reflectingtherefrom.
 19. The catheter tip apparatus as recited in claim 18,wherein said housing has accumulation components defining a fiberalignment slot for miniaturization of said tip.
 20. A catheter tipapparatus arranged in a catheter for the delivery and collection of anenergy signal to permit subsequent computerized analysis of body tissueby the collected signal, comprising: an elongated housing having alongitudinal axis of rotation, said housing having a first reflectivesurface disposed thereon; a second reflective surface disposed on saidhousing distally of said first reflective surface and in axial alignmenttherewith; and a first light conductive fiber in light-coupledcommunication with said first reflective surface and a second lightconductive fiber in light-coupled communication with said secondreflective surface, said first light conductive fiber in communicationbeing in communication with a controlled analytical-light-generatingsource and said second light conductive fiber being in communicationwith a light-collection analysis device.
 21. The catheter tip apparatusas recited in claim 20, wherein said first reflective surface isdimensionally larger than said second reflective surface.
 22. Thecatheter tip apparatus as recited in claim 20, wherein said firstreflective surface is curvilinear.
 23. The catheter tip apparatus asrecited in claim 20, wherein said first reflective surface isnon-parallel with respect to said second reflective surface.
 24. Thecatheter tip apparatus as recited in claim 20, wherein at least one ofsaid first and second reflective surfaces are spaced apart from saidlight conductive fibers.
 25. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface is disposed radiallywithin and spaced from the perimeter of said housing to permit aspreading of a light beam from said first reflective surface onto saidbody tissue.
 26. The catheter tip apparatus as recited in claim 24,having an index matching fluid arranged between a distal end of saidconductive fiber and said reflective surface.
 27. The catheter tipapparatus as recited in claim 24, wherein said reflective surface ispositioned in a holding pocket arranged in said housing.
 28. Thecatheter tip apparatus as recited in claim 27, wherein said reflectivesurface comprises a mirrored member.
 29. The catheter tip apparatus asrecited in claim 27, wherein said holding pocket is utilized to alignsaid reflective surface with respect to said housing.
 30. The cathetertip apparatus as recited in claim 20, wherein said conductive lightfibers are each individually arranged within a bore disposed within saidhousing.
 31. The catheter tip apparatus as recited in claim 20, whereinsaid light delivery fibers are equally diametrically opposed about saidaxis of rotation of said housing to provide balance thereto and minimizeeccentricity during rotation thereof.
 32. The catheter tip apparatus asrecited in claim 20, wherein said first reflective surface and saidsecond reflective surface are disposed at an angle proportional to thenumerical aperture of said first and second fibers, to yield a lightbeam with adjacent edges that are parallel to one another, to permit adistance independent delivery reflector-collector reflector separation.33. A catheter tip apparatus arranged in a catheter for the delivery andcollection of an energy signal to permit subsequent computerizedanalysis of body tissue by the collected signal, comprising: anoptically transparent sheath enclosed elongated housing having alongitudinal axis of rotation, said housing having a first reflectivesurface disposed thereon; a second reflective surface disposed on saidhousing distally of said first reflective surface and in axial alignmenttherewith; a first light conductive fiber in light coupled communicationwith said first reflective surface and a second light conductive fiberin light coupled communication with said second reflective surface, saidfirst light conductive fiber in communication being in communicationwith a controlled analytical-light generating source and said secondlight conductive fiber being in communication with a light-collectionanalysis device; and a generally curvilinear cover arranged to mate overa distal portion of said housing to enclose said reflective surfaces,said cover having at least one opening on an annular surface thereof topermit light delivery to said body tissue, and to permit lightcollection therethrough upon reflection from said body tissue.
 34. Thecatheter tip apparatus as recited in claim 33, wherein at least one ofsaid reflective surfaces comprises a mirrored member.
 35. The cathetertip apparatus as recited in claim 34, wherein each of said lightconductive fibers has a distal end arranged within said housing, andsaid at least one of said light conductive fibers is in abuttingrelationship with a non-reflective surface of said mirrored member. 36.The catheter tip apparatus as recited in claim 33, wherein at least oneof said reflective surfaces is disposed in a holding pocket.
 37. Thecatheter tip apparatus as recited in claim 36, wherein said reflectivesurface is secured in said holding pocket by an adhesive.
 38. Thecatheter tip apparatus as recited in claim 33, wherein an index matchingfluid is disposed about said reflective surfaces to minimize backreflections thereto, from said outer sheath.
 39. A catheter tipapparatus arranged in a catheter for the delivery and collection of anenergy signal to permit subsequent computerized analysis of body tissueby the collected signal, comprising: an optically transparent sheathenclosed elongated housing having a longitudinal axis of rotation, saidhousing having a first reflective light delivery surface disposedthereon; a first reflective light collection surface disposed on saidhousing distally of said first reflective light delivery surface and inaxial alignment therewith; a first light conductive fiber in lightcoupled communication with said first reflective light delivery surfaceand a second light conductive fiber in light coupled communication withsaid first reflective light collection surface, said first lightconductive fiber in being in communication with a controlledanalytical-light generating source and said second light conductivefiber being in communication with a light-collection analysis device;and a second reflective light collection surface disposed on saidhousing distally of said first reflective light collection, said secondreflective collection surface also in communication with said controlledanalytical-light generating source and in axial alignment therewith;said first and second reflective surfaces arranged to permit deep tissuelight energy penetration and collection and analysis thereby.
 40. Thecatheter tip apparatus as recited in claim 39, wherein said first andsecond light collection surfaces collect light emitted from a commonlight delivery source.
 41. A method of delivering and collecting atissue-striking light energy signal from a first light bearing memberand adjacent delivery beam redirecting member and returning said lightenergy signal to a collection beam redirecting member adjacent a secondlight bearing member for analysis and tissue treatment, in a lightbearing arrangement, including: spacing said collection beam redirectingmember distally of said delivery beam redirector member in a sheathenclosed elongated catheter housing tip, said housing having alongitudinal axis; disposing said beam redirecting members at an anglewith respect to said longitudinal axis of said elongated housingproportional to a numerical aperture of said first and second energyfibers.
 42. The method as recited in claim 41, including: bathing saidreflectors in an index matching fluid to minimize back reflection insaid sheath enclosed housing.
 43. The method as recited in claim 41,including: directing said delivery light energy signal and saidcollection light energy signal so as to yield adjacent edges thereofthat are parallel.
 44. The method as recited in claim 41, including:delivering and collecting light from common fibers in said light fiberbearing arrangement.
 45. The method as recited in claim 41, wherein saidnumerical apertures for each of said beam redirectors are different fromone another.
 46. The method as recited in claim 41, wherein said beamredirectors are reflectors.
 47. The method as recited in claim 41,wherein said beam bearing members comprise optical fibers.
 48. Themethod as recited in claim 41, wherein said beam bearing memberscomprise waveguides.